Treatment of Primary Membranous Nephropathy with a New Monoclonal Antibody

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy

This study is testing a new injectable antibody treatment for people with primary membranous nephropathy to see if it is safe and how well it works.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd (Industry-sponsored)
• Locations: 6 sites (Zhengzhou, He'nan and 5 other locations)
• Trial ID: NCT05668403 on ClinicalTrials.gov

What this trial studies

This Phase I clinical study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of a recombinant humanized anti-CD20 monoclonal antibody administered via subcutaneous injection for patients with primary membranous nephropathy. The study aims to determine preliminary efficacy and gather data on how the drug behaves in the body. Participants will be closely monitored to assess their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of primary membranous nephropathy.

Not a fit: Patients with secondary membranous nephropathy or those requiring renal replacement therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from primary membranous nephropathy.

How similar studies have performed: While this approach is novel, similar studies targeting B-lymphocyte antigens have shown promise in other conditions.

Eligibility criteria

Inclusion Criteria:

1. Subjects who have fully understood this study and voluntarily signed the informed consent form;
2. Male or female subjects, aged between 18 and 75 years;
3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
6. Subjects who are able to follow the study protocol as judged by the investigator.

Exclusion Criteria:

1. Subjects with secondary membranous nephropathy;
2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
4. Subjects who have received or are receiving renal replacement therapy;
5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；
9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
12. Subjects with a history of alcoholism or drug abuse within 12 months;
13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
14. Subjects with CD4+ T lymphocyte count \< 300 cells/μL;
15. Other conditions unsuitable for participation in this study determined by the Investigator.

Where this trial is running

Zhengzhou, He'nan and 5 other locations

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, He'nan, China (Recruiting)
• Hebei General Hospital — Shijiazhuang, Hebei, China (Recruiting)
• The First Affiliated Hospital,College of Medicine,Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Peking university first hospital — Beijing, China (Recruiting)
• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, China (Recruiting)
• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Minghui Zhao

Conditions Primary Membranous Nephropathy